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NCT ID: NCT02962765 Completed - Hemophilia A Clinical Trials

Non-interventional Post-authorisation Study to Document the Immunogenicity, Safety, and Efficacy of NUWIQ

Start date: January 2015
Phase:
Study type: Observational

Prospective, multinational, non-interventional post-authorisation study to collect additional clinical data and to ensure consistency in the long-term between the outcome from pre-authorisation clinical studies (in 135 previously treated paediatric and adult patients) and routine clinical practice. Besides aspects such as general product safety and efficacy, there will be a focus on immunogenicity, particularly on inhibitor development. The diagnosis of FVIII inhibitor will be based on clinical observations and confirmed by FVIII inhibitor testing in the laboratory.

NCT ID: NCT02958865 Completed - Ulcerative Colitis Clinical Trials

Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

Start date: February 3, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.

NCT ID: NCT02955355 Completed - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Long-Term Tolerability and Safety of HYQVIA/HyQvia in CIDP

Start date: December 12, 2016
Phase: Phase 3
Study type: Interventional

Adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who have completed study 161403 will be able to take part in this study. The main aim of the study is to evaluate side effects in the long-term treatment with HYQVIA/HyQvia. All participants will receive HYQVIA/HyQvia in the same way as they were receiving in study 161403. The dosing interval of HYQVIA/HyQvia can be adjusted after 12 weeks of treatment in study 161505 if the study doctor determines that it is safe to do so. Participants will visit the clinic within 1 week after the first and second dose of HYQVIA/HyQvia and then every 12 weeks for the duration of the study.

NCT ID: NCT02943720 Completed - Allergic Rhinitis Clinical Trials

ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen

ATIBAR
Start date: September 2016
Phase: Phase 2
Study type: Interventional

A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis

NCT ID: NCT02941926 Completed - Breast Cancer Clinical Trials

Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC

COMPLEEMENT-1
Start date: November 30, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..

NCT ID: NCT02935608 Completed - Clinical trials for Lumbosacral Radiculopathy

Study to Evaluate the Efficacy and Safety of BIIB074 in Neuropathic Pain From Lumbosacral Radiculopathy

RELAY-1
Start date: October 31, 2016
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of two dose regimens of BIIB074 on neuropathic pain in participants with pain from lumbosacral radiculopathy (PLSR). Secondary objectives are to evaluate the efficacy of 2 dose regimens of BIIB074 on additional neuropathic pain measures and assessments of low back pain, disability, and quality of life; To investigate the safety and tolerability of 2 dose regimens of BIIB074 and To characterize the pharmacokinetics (PK) of BIIB074 in this population.

NCT ID: NCT02929329 Completed - Heart Failure Clinical Trials

Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction

GALACTIC-HF
Start date: January 6, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF).

NCT ID: NCT02928406 Completed - Clinical trials for Urinary Tract Cancer

A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract

Start date: November 30, 2016
Phase: Phase 3
Study type: Interventional

This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with atezolizumab.

NCT ID: NCT02926950 Completed - Clinical trials for Type 2 Diabetes Mellitus

Efficacy and Safety of Sotagliflozin Versus Placebo in Patients With Type 2 Diabetes Mellitus on Background of Metformin

Start date: November 2016
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the superiority of Sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control with metformin. Secondary Objectives: - To compare Sotagliflozin versus placebo for. - Change from baseline in 2-hour postprandial glucose (PPG) following a mixed meal. - Change from baseline in fasting plasma glucose (FPG). - Change from Baseline in systolic blood pressure (SBP) for participants with baseline SBP ≥130 millimeter of mercury (mmHg). - Change from baseline in SBP for all participants. - Change from baseline in body weight. - Proportion of participants with HbA1c <6.5% and <7.0%. - To evaluate the safety of Sotagliflozin versus placebo.

NCT ID: NCT02924727 Completed - Clinical trials for Acute Myocardial Infarction

Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI

PARADISE-MI
Start date: December 9, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily.